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Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.

How to Track Regulatory Correspondence in Kivo

Tracking agency commitments is essential for obvious reasons, but can be stressful without a system or process to manage them. With Kivo'sCorrespondence Tracking,you'll never have to...

22 August 2024
1 min read

How to Review and Approved Controlled Documents in Kivo

Document authoring is one of the most essential activities in Regulatory, Clinical, and Quality operations. Regulations such as CFR Part 11 requiring compliant e-Signatures dictate the way...

8 August 2024
1 min read

How to Manage Projects Efficiently with Automated Reporting

One of the more challenging aspects of clinical trial management is visibility. The sheer number of outsourced partners - sites, CROs, writers, consultants, vendors, etc - who often have...

8 August 2024
1 min read

A Guide to Regulatory Submissions in the US (FDA) & EU (EMA)

If you're new to regulatory submissions, they can seem a little confusing - and not just because there are some many acronyms to learn. To help you navigate the landscape, we offer this...

8 July 2024
5 min read

How to Manage Regulatory Projects and Content Plans in Kivo

Regulatory content planning is a foundational step for any regulatory submission. A regulatory content plan is a outline of the pieces of content required for the submission, their due...

13 June 2024
2 min read

Accelerate Quality Operations with Automatic Quality Templates

Quality operations, by definition, follow repeatable processes. Therefore, finding small-but-meaningful ways to accelerate these processes can add up to large time savings over time, and...

9 May 2024
1 min read

How to Link Documents Directly to your eCTD Submission

Imagine you have assembled your regulatory submission after months (or even years!) of effort. It is now time to send it to a publisher to compile into the correct format for submission to...

11 April 2024
1 min read

TMF Breakdown: What Constitutes a Trial Master File?

At the heart of clinical trial documentation lies the Trial Master File (TMF), a comprehensive repository of essential documents and data pertaining to the trial. Let’s discuss this...

29 February 2024
3 min read

Kivo GO Feature Round Up: Clinical Updates

Rounding out our Feature Round Up series, this article will showcase some of the new clinical capabilities of our eTMF. To read more about the overall features of Kivo GO, our new Quality...

30 November 2023
5 min read

Kivo GO Feature Round Up: Regulatory Updates

Alongside the launch of our QMS, we’ve also made some big improvements to our regulatory management capabilities. In this article, we’ll outline what’s new and how those changes can...

20 November 2023
3 min read